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The Effect on Fluid Balance After Cardiac Surgery After Use of Two Different Priming Protocols

Sponsor
Haukeland University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01511120
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
25
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

"The impact on fluid loading after cardiac surgery by use of two different priming solution"

Fluid overloading with oedema formation is a regular finding following on-pump cardiac surgery and may contribute to postoperative organ dysfunction. Myocardial oedema has been reported to impair both systolic and diastolic function. An association between intraoperative fluid loading and postoperative adverse outcome has been demonstrated in cardiac patients.

The investigators have experience with the use of both colloides and combination fluids (hypertonic saline/colloides) in several experimental studies (pigs). In one animal study the investigators used colloides as an additive to the CPB-prime. The investigators observed reduced fluid leakage and less total tissue water in several organs.

The planned study includes patients scheduled for coronary artery bypass, and who have no co-morbidity. The patients will be randomized to receive either Tetraspan® (HES) or acetated Ringer's solution in the CPB-prime. Accurate accounts of fluid additions, blood loss and diuresis will be kept. Determination of cardiac output (C.O.), intrathoracic blood volume (ITBV), extravascular lung water (EVLW) and global end diastolic volume (GEDV) will be monitored by use of the transpulmonary thermodilution technique PiCCO®plus system.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Ringer's Acetat Versus Balanced Hydroxyethyl-starch as Primesolution in the Heart-lung Maschine During Cardio-pulmonary-bypass. Postoperatively Fluid Balance and Cardiac Function
Study Start Date :
Nov 1, 2011
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Tetraspan

Drug: Tetraspan
Other Names:
  • Tetraspan® (HES 130/0,42 , 6%),
  • B. Braun Medical AS
  • Kjernåsveien 13 B
  • 3142 Vestskogen

    • Drug: acetated Ringer's solution

    Outcome Measures

    Primary Outcome Measures

    1. Reduction of organ edema and improved organ function [6-hours postoperatively]

      As a target of effect the investigators have chosen to study improvements for organ function.Indexed values for cardiac output(CI) measured by the PICCO system will be a parameter for heart function, andf lung function will be measured by EVLWI(extravascular lungwater index).paO2/FiO2-ratio and time spent in respirator.Additionally a strict account for fluid balance will be kept.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients undergoing CABG,

    • EF(ejection fraction) more than 40%

    Exclusion Criteria:

    • Reduced EF (less than 40%) EVF less than 30%,

    • Estimated GFR less than 60%,

    • BMI less than 18 or more than 32

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hjerteavdelingen, thoraxkirurgisk seksjon, Haukeland Universitetssykehus Bergen Norway 5021

    Sponsors and Collaborators

    • Haukeland University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Haukeland University Hospital
    ClinicalTrials.gov Identifier:
    NCT01511120
    Other Study ID Numbers:
    • 2011/498
    First Posted:
    Jan 18, 2012
    Last Update Posted:
    May 12, 2015
    Last Verified:
    Aug 1, 2013
    Additional relevant MeSH terms:
    Heart Diseases
    Coronary Disease
    Coronary Artery Disease
    Myocardial Ischemia

    Study Results

    No Results Posted as of May 12, 2015